# K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500

- Pathway: 510(k) (Special)
- Applicant: Cardiacassist, Inc.
- Decided: Aug 22, 2006 after 97 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K852698 (1985). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991783: AB-180 XC System, Model AB-180XC, Cardiacassist, Inc. (2000) Summary page 1.

## Most influential descendants
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own
- K073631: Orqis Extracorporeal Blood Pumping System, Model BPS-100 (2008), 0 descendants of its own

## Indications for use
The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

Source page: https://510kreport.com/device/K061369
Methodology: https://510kreport.com/methodology